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NCT Number: NCT07679945

A Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Participants

The study aims to evaluate the efficacy of a facial sunscreen under two experimental conditions-untinted and tinted-in improving facial spots (melasma and solar lentigines/post-inflammatory hyperpigmentation) after 8 weeks of product use under normal conditions by adult participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ALS Beauty & Personal Care Ltda

Campinas, São Paulo, 13084-791, Brazil

Location status: Recruiting

Location contact

Gabrielli Brianezi

CONTACT

[email protected]

+551937898600

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to understand and follow study instructions
  • Fitzpatrick skin types I-VI
  • Presence of facial hyperpigmentation, such as:
  • Mild to moderate melasma, or
  • Visible dark spots (e.g., solar lentigines or post-inflammatory hyperpigmentation)
  • Willing to comply with study procedures and product use
  • For subjects in applicable groups: willing to use assigned sunscreen product

Exclusion criteria

  • Known sensitivity or allergy to cosmetic or skincare products
  • Skin conditions or lesions in the study area that could interfere with evaluation (e.g., active dermatitis, infections, significant irritation, or extensive scarring)
  • Use of medications or products that may interfere with study evaluations
  • Recent cosmetic or dermatological procedures in the study area (e.g., chemical peels, laser treatments, invasive procedures)
  • Excessive sun exposure or use of tanning beds immediately prior to or during the study
  • Pregnancy or intention to become pregnant during the study
  • Participation in another clinical study within a recent period
  • Any condition or situation that, in the investigator's judgment, may interfere with study participation or evaluation of results

Treatment and study plan

Sunscreen untinted

Other

Participants will apply the facial sunscreen on the face at least twice daily for 56 days

Sunscreen tinted

Other

Participants will apply the facial sunscreen on the face at least twice daily for 56 days

Primary outcomes

  1. Clinical efficacy of change in hyperpigmentation assessed via dermatological evaluation

    Time frame: Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use

  2. Instrumental measurements with the Chroma Meter CR 400 (Konica Minolta)

    Time frame: Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use

    Measurements will be taken using the Chroma Meter® CR 400 to evaluate the color intensity of the dark spot (Melasma, Solar Lentigo, or Post-Inflammatory Hyperpigmentation) in comparison to the measurement of an adjacent area (without a spot).

  3. Capture of facial images using the Visia-CR® Facial Imaging Booth (Canfield Scientific, Inc.)

    Time frame: Before, immediately after the first application, and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use

    Facial images will be captured using the Visia CR® Facial Imaging Booth (Canfield Scientific, Inc.) for analysis of the intensity and size of the spot (Melasma, Solar Spot, or Post-Inflammatory Hyperpigmentation), as well as the overall uniformity of skin tone.

  4. Participants' quality of life regarding facial spots for participants with Melasma assessed through a Quality of Life Questionnaire (MELASQoL)

    Time frame: Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use

    Melasma Quality of Life Scale (MELASQoL) will only be answered by participants enrolled in Melasma group.

    The participant will answer a questionnaire with 10 questions regarding the condition of their skin, using a rating scale from 1 to 7, in which: 1 means "not at all bothered" and 7 means "bothered all the time". A total score will be generated by summing the scores of the 10 questions answered by the participant. The total score ranges from 10 to 70. The lower the score, the better the participant's quality of life.

  5. Participants' quality of life regarding facial spots for participants with Solar Lentigo or Post-Inflammatory Hyperpigmentation assessed through a Quality of Life Questionnaire (DLQI)

    Time frame: Before and after Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use

    Dermatology Life Quality Index (DLQI) will only be answered by participants selected for the Solar Lentigo/PIH Group. The participant will answer a questionnaire with 10 questions regarding the impact of their skin on their quality of life. Each question is scored on a four-point Likert scale: very much = 3 points, much = 2 points, a little = 1 point and nothing/not relevant = 0 points. Questions answered as nothing and not relevant are equivalent to 0 points. The total score ranges from 0 to 30. The lower the score, the better the participant's quality of life.

  6. Perceived efficacy assessed through perception questionnaires completed by the research participants

    Time frame: After Visit 2 (14+2 days), Visit 3 (28+2 days), and Visit 4 (56+2 days) of IP use

    Participants will answer a questionnaire evaluating their individual opinion about the Investigational Product used. Questionnaire consists of 9 questions which should be answered in a 5-point scale of agreement (such as ranging from "Strongly Disagree" to "Strongly Agree").

  7. Open emotional testimonial written by the participant at the end of IP use

    Time frame: After Visit 4 (56+2 days) of IP use

    Consists of an open-ended, narrative question in which the participant provides a brief statement regarding their experience with the use of their respective Investigational Product.

Study contacts

Contact information is provided by the study sponsor or research team.

Kenvue Global Clinical Operations

CONTACT

[email protected]

18779295131

Sponsors and collaborators

Lead sponsor

Kenvue Brands LLC

Industry

Registry information

Official study title

A Monocentric and Open-Label Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Research Participants

Acronym: El Porto Ex-US

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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